NCT01983735

Efficacy and Safety of TELMINUVO to Stage 2 Hypertension

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Telmisartan and S-Amlodipine(TELMINUVO TAB.) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.

Detailed description

* In patients with Stage 2 hypertension to determine the efficacy and safety of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 8 weeks. * This study is consist of placebo run-in period(2 weeks\_single blind) and treatment period(8 weeks\_double blind).

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	TELMINUVO Tab. (80/2.5mg)	* Fixed dose combination of Telmisartan 80mg and S-amlodipine 2.5mg QD 2 weeks. * With the others investigation product placebo 1 tab QD 2 weeks.
DRUG	TELMINUVO Tab. (80/5mg)	* Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks. * With the others investigation product placebo 1 tab QD 6 weeks.
DRUG	S-amlodipine 2.5mg	* S-amlodipine 2.5mg QD 2 weeks * With the others investigation product placebo 1 tab QD 2 weeks.
DRUG	S-amlodipine 5mg	* S-amlodipine 5mg QD 6weeks * With the others investigation product placebo 1 tab QD 6 weeks.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-11-14
• Last updated: 2013-11-14

Locations

1 site across 1 country: South Korea